Managing Director and Principal Consultant
Greg has been privileged to work in the Pharmaceutical and Medical Device field for approaching 20 years, the last 15 years in Regulatory Affairs. Prior to founding Plunkett Consulting in 2007, Greg was Regulatory Affairs and Clinical Development Manager for a Melbourne based device/pharmaceutical company and was responsible for all activities relating to the domestic and international registrations, clinical development strategy and trial management.
Prior to this role, Greg worked within CSL Limited (now named as Seqirus) where he directly managed the registration of manufactured and in-licensed pharmaceuticals, including being a founding member of CSL’s regulatory team responsible for the initial approval of the companys’ Influenza Vaccine with the FDA.
Previous roles including manufacturing/formulation development and quality assurance/quality control roles. Greg has directly managed the development of various therapeutic goods, from early pre-clinical evaluation through to marketing approval. He has direct experience in obtaining marketing approval in various jurisdictions, including the Australia, New Zealand, US, Europe, Canada and South East Asia. Greg has a Bachelor of Applied Science (Monash) and a Masters of Medical Science (University of NSW).
Head of Clinical Operations/Clinical Consultant
Rosa brings to the team 20 years’ experience in clinical research. Rosa commenced her career as a Clinical Research Coordinator at The Royal Melbourne Hospital and worked within the department of Nephrology.
To progress her career and widen her therapeutic area experience, Rosa joined an Australian clinical research organization, where she progressed from a Clinical Research Associate role, to a Clinical Team leader and Project Manager. While in these roles, Rosa had the opportunity to work across all aspects of clinical research both in Australia and Asia Pacific, specializing in all phases of clinical research from Phase I to IV.
Rosa directs study management experience in various therapeutic areas including oncology, haematology and Nephrology. Rosa brings a wealth of key competencies, and experience from her extensive experience in clinical research. Rosa has Bachelor of Applied Science (Monash) and is GCP certified.
Senior Regulatory Consultant/Project Manager
Sarah joined Accelagen after period working in the United Kingdom for Actavis (recently acquired by Teva Pharmaceutical Industries). There she gained experience and knowledge in working in the European regulatory field (including in National and Mutual Recognition/Decentralised Procedures) and interacting with a number of the key regulatory agencies, such as MHRA, BfArM and ANSM.
During her time in Europe she also gained her Regulatory Affairs Certification (RAC) in European Regulatory Affairs. Prior to this, Sarah spent several years working for CSL in Australia, where she worked on a variety of regulatory projects in prescription medicines, from New Chemical entity (NCE) submissions through to lifecycle regulatory activities. Her time at CSL also involved growing and maintaining relationships with key European partners.
Complementary to her experience in regulatory affairs, Sarah also spent several years working for IP Australia, (the National Patent office) where she worked on assessing and administrating pharmaceutical patents. Sarah holds a Bachelor of Arts/Bachelor of Science (Hons.) majoring in Biochemistry from the University of Melbourne.
Chris joined the Accelagen after his retirement from the Therapeutic Goods Administration (the Australian National Regulatory Authority) in August 2014 after 26 years of vaccine regulation. During his time with TGA, Chris provided and managed regulatory services, including Lot Release and direct QC testing for vaccines for supply in Australia, review of marketing application dossiers, for both vaccine quality. Also, Chris has been instrumental in enhancing Bacterial Endotoxin safety in pharmaceuticals more broadly, and in specialist inspection of manufacturers in Australia and overseas. Chris is held in high regard in the industry for his accumulated expertise and open advice in both vaccine quality issues and regulatory systems more generally. Chris also had the opportunity to work closely with the World Health Organisation, both through TGA and “on secondment” to Geneva, and was involved in the development of the vaccine regulatory strengthening program from it’s inception and in providing specialist advice to the vaccine pre-qualification program. He has assessed and advised vaccine regulators & manufacturers around the world, and conducted and advised in training courses on a global basis, in all aspects of vaccine quality and regulation. Many of those who have trained under Chris are now experts with WHO and in vaccine regulators & manufacturers around the world.